Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN Tablets, at 2-3 Stages of Rehabilitation of Patients With Post Intensive Care Syndrome

Polysan

Status: Enrolling

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT06735898

PR-C_2

Details and patient eligibility

About

Post intensive care syndrome (PIC syndrome) is an important problem in modern intensive care strategy. Understanding the mechanisms of PIC syndrome helps prevent it in patients with respiratory, neuromuscular transmission, and cognitive impairments that require prolonged support of vital functions. Significant role in the formation and severity of PIC syndrome is played by the severity of the systemic inflammatory response, which is an individual reaction of the body, and this determines the degree of neurological and psychological deficits. Chronic diseases such as diabetes mellitus, especially in the context of metabolic syndrome, worsen the course of PIC syndrome and delays recovery. Early initiation of rehabilitation measures in the intensive care unit and subsequent expansion of the individual rehabilitation program contributes to the rapid and successful recovery of not only vital functions, but also cognitive, motor and emotional disorders. This shortens the hospital stay of patient and improves their quality of life after discharge.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 18 years of age and older;
• Stay in the ITU and (or) intensive care unit for at least 3 days;
• Diagnosed "post intensive care" syndrome (PIC syndrome) with moderate-to-severe severity >3<6 points
• Diagnosed modalities "critical illness polyneuropathy, respiratory neuropathy, dysphagia" of the domain "Neuromuscular complications" of PIC syndrome at 2-3 stages of the rehabilitation route at any value of PICS severity index
• Diagnosed modalities "decreased gravitational gradient, decreased exercise tolerance" in the domain "Vegetative-metabolic complications" at 2-3 stages of the rehabilitation route at any value of PICS severity index

Exclusion criteria

• Premorbid level of vital activity when assessed on the rehabilitation routing scale 4-5 points;
• Hematocrit ≤30%;
• Hemoglobin level ≤80 g/L;
• Acute cardiac failure;
• Acute respiratory failure;
• Acute renal failure;
• Acute liver cell failure;
• Use of drugs from "metabolic agents" pharmacotherapeutic group at the time of inclusion in the study
• Life expectancy of 6 months or less or presence of incurable diseases in decompensation stage

Trial design

90 participants in 2 patient groups

Group 1

Description:

Basic therapy + Cytoflavin® intravenous solution in the volume of 20 ml per day IV drip in dilution on 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution during 10 days, transition to Cytoflavin® tablets from the next day after the end of intravenous administration during the next 75 days according to the instructions for medical use

Group 2

Description:

Basic therapy, according to clinical guidelines (clinical practice established within the center) for the treatment of patients in stages 2-3 of rehabilitation.